GSK takes one in the eye

November 13, 2014

An eye ointment to treat herpes infections has been recalled amid safety concerns arising from the presence of metal fragments in the cream.

Drugs giant GlaxoSmithKline (GSK) has issued an urgent recall of two batches of its Zovirax Opthalmic Ointment (aciclovir 3%) after discovering that they were manufactured using active pharmaceutical ingredients that failed specifications regarding the presence of particulate matter.

The ointment is used for the treatment of herpes simplex virus infections of the eye. It works by stopping the production of the herpes simplex virus, though it does not get rid of the virus from the body.

“The main safety concern is for potential particles to physically damage the eye,” GSK’s Associate Medical Director Dr Navib Singh said, adding that the fragments had been identified as “metal filaments”.

“As we are not able to assess the quantity and the size of potential metal particles in the finished products, we are taking the precautionary measure…to undertake a recall of all affected batches,” Dr Singh said. “Patients should be urged to consult their specialist before ceasing treatment with this product.”

He said the company was undertaking a thorough investigation of its manufacturing processes to ensure there was no repeat of the incident and warned that, as a result, “supply [of the ointment] is constrained”.

Dr Singh said this was likely to mean it would be in short supply, if not completely unavailable, until at least the June quarter 2015.